Lung Cancer Clinical Trial

Tislelizumab in Combination With Sitravatinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Summary

The purpose of this study is to evaluate the efficacy and safety of tislelizumab in combination with sitravatinib compared with docetaxel in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have disease progression following platinum-based chemotherapy and anti-programmed cell death protein-1 (PD-1)/programmed cell death ligand-1 (PD-L1) antibody, with the anti-PD-(L)1 antibody administered in combination with or sequentially before or after the platinum-based chemotherapy.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

Metastatic or unresectable locally advanced histologicallyor cytologically confirmed Non-Small Cell Lung Cancer (NCSLC), not amenable to treatment with curative intent
Able to provide archival/fresh tumor tissues for biomarker analysis to assess PD-L1 expression and other biomarkers.
No known Epidermal Growth Factor Receptor (EGFR) or B-Raf proto-oncogene (BRAF) sensitizing mutation, or anaplastic lymphoma kinase (ALK) rearrangement or ROS proto oncogene 1 (ROS1) rearrangement
Radiographic progression per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 on or after anti-PD-(L)1 containing therapy for locally advanced and unresectable or metastatic NSCLC.
No prior anticancer therapy having the same mechanism of action as sitravatinib (eg, tyrosine kinase inhibitor with a similar target profile or Vascular endothelial growth factor (VEGF)- or VEGFR inhibitor)
At least 1 measurable lesion as defined based on RECIST v1.1 by investigator

Key Exclusion Criteria:

Has received docetaxel as monotherapy or in combination with other therapies.
Squamous NSCLC with central cavitation, or NSCLC with hemoptysis (> 50 mL/day)
Participants with tumor shown by imaging to be located around important vascular structures or if the investigator determines that the tumor is likely to invade important blood vessels and may cause fatal bleeding.
Active leptomeningeal disease for metastatic NSCLC, or uncontrolled or untreated brain metastasis.
Active autoimmune diseases or history of autoimmune diseases that may relapse.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

420

Study ID:

NCT04921358

Recruitment Status:

Recruiting

Sponsor:

BeiGene

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There are 93 Locations for this study

See Locations Near You

Genesis Cancer Center
Tucson Arizona, 71913, United States
Scripps Health
La Jolla California, 92037, United States
Helen F Graham Cancer Center-Christiana Care
Newark Delaware, 19713, United States
University Medical Center New Orleans
New Orleans Louisiana, 70121, United States
University of Mississippi Medical Center
Jackson Mississippi, 32916, United States
Nebraska Cancer Specialists
Omaha Nebraska, 68130, United States
University of Nebraska Medical Center
Omaha Nebraska, 68198, United States
Hunterdon Hematology Oncology
Flemington New Jersey, 08822, United States
Summit Medical Group, PA
Florham Park New Jersey, 07932, United States
Atlantic Health System/Morristown Medical Center
Morristown New Jersey, 07960, United States
Ny Cancer And Blood Specialists
Port Jefferson Station New York, 11776, United States
Clinical Research Alliance, Inc.
Westbury New York, 11590, United States
TriHealth Cancer Institute
Cincinnati Ohio, 45242, United States
The James Thoracic Oncology Center
Columbus Ohio, 43201, United States
Ohio State University Comprehensive Cancer Center
Columbus Ohio, 43210, United States
Ohio State University Hospital
Columbus Ohio, 43210, United States
Thomas Jefferson University Hospital - Central
Philadelphia Pennsylvania, 19107, United States
Charleston Oncology, P.A.
Charleston South Carolina, 29414, United States
Hematology/Oncology Knoxville, TN
Knoxville Tennessee, 37909, United States
X-Cancer/Tennessee Cancer Specialists
Knoxville Tennessee, 37909, United States
Brooke Army Medical Center (BAMC)
Fort Sam Houston Texas, 78234, United States
San Antonio Military Medical Center (SAMMC)
Fort Sam Houston Texas, 78234, United States
D/B/A UT Health East Hope Cancer Center
Tyler Texas, 75701, United States
The University of Texas Health Science Center at Tyler
Tyler Texas, 75701, United States
Fort Belvoir Community Hospital (Geneva Foundation)
Fort Belvoir Virginia, 22060, United States
Cancer Care Northwest
Spokane Valley Washington, 99216, United States
Blacktown Cancer and Haematology Centre
Blacktown New South Wales, 2148, Australia
Campbelltown Hospital
Campbelltown New South Wales, 2560, Australia
St George Hospital
Kogarah New South Wales, 2217, Australia
The Tweed Hospital
Tweed Heads New South Wales, , Australia
Cairns and Hinterland Hospital and Health Service
Cairns Queensland, 4870, Australia
Gallipoli Medical Research Foundation (Greenslopes Private Hospital)
Greenslopes Queensland, 4120, Australia
Cancer Research South Australia
Adelaide South Australia, 5000, Australia
Monash Health
Clayton Victoria, , Australia
St Vincent's Hospital Melbourne
East Melbourne Victoria, 3002, Australia
Northern Hospital
Epping Victoria, 3076, Australia
Sunshine Hospital, Western Health
Saint Albans Victoria, 3021, Australia
Pindara Private Hospital
Benowa , 4217, Australia
Anhui Cancer Hospital aka West Branch of Anhui Province Hospital
Hefei Anhui, 23000, China
Beijing Cancer Center
Beijing Beijing, 10014, China
Peking Union Medical College Hospital - Oncology
Beijing Beijing, 10073, China
Beijing Cancer Hospital
Beijing Beijing, , China
Cancer Hospital Chinese Academy of Medical Science
Beijing Beijing, , China
Xinqiao Hospital Affiliated to The Army Medical University
Chongqing Chongqing, 40003, China
Daping Hospital, Third Military Medical University
Chongqing Chongqing, 40004, China
Fujian Provincial Cancer Hospital
Fuzhou Fujian, 35001, China
First Affiliated Hospital of Xiamen University
Xiamen Fujian, 36100, China
First Hospital of Lanzhou University
Lanzhou Gansu, 73000, China
Cancer Center of Guangzhou Medical University
Guangzhou Guangdong, 51005, China
Guangdong Provincial People's Hospital
Guangzhou Guangdong, 51008, China
Nanfang Hospital of Southern Medical University
Guangzhou Guangdong, 51051, China
Cancer Hospital of Shantou University Medical College - Oncology
Shantou Guangdong, 51503, China
Affiliated Tumor Hospital of Guangxi Medical University
Nanning Guangxi, 53002, China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning Guangxi, 53002, China
Harbin Medical University Cancer Hospital
Harbin Heilongjiang, 15008, China
Henan Cancer Hospital
Zhengzhou Henan, 45000, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou Henan, 45005, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan Hubei, 43002, China
Tongji Hospital of Tongji Medical College Huazhong University of Science Technology
Wuhan Hubei, 43003, China
Hubei cancer hospital
Wuhan Hubei, 43007, China
The Second Xiangya Hospital central South University
Changsha Hunan, 41001, China
The First People's Hospital of Chenzhou
Chenzhou Hunan, 43040, China
The Second Hospital, University of South China
Hengyang Hunan, 43040, China
Nanjing First Hospital
Nanjing Jiangsu, 21000, China
Zhongda Hospital Southeast University
Nanjing Jiangsu, 21000, China
The Second Affiliated Hospital of Soochow University
Suzhou Jiangsu, 21500, China
The First Affiliated Hospital of Soochow University
Suzhou Jiangsu, , China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou Jiangsu, 22100, China
The Second Affiliated Hospital of Nanchang University
Jiangxi Jiangxi, 33000, China
The First affiliated hospital of Nanchang University
Nanchang Jiangxi, 33000, China More Info
Jianping Xiong
Contact
The First Hospital of Jilin University
Changchun Jilin, 13002, China
The First Hospital of Dalian Medical University
Dalian Liaoning, 11604, China
Liaoning Cancer Hospital & Institute - Medical Oncology - Oncology
Shenyang Liaoning, 11001, China
General Hospital of Ningxia Medical University
Yinchuan Ningxia, , China
Jinan Central Hospital
Jinan Shandong, 25001, China
Shandong Cancer Hospital
Jinan Shandong, 25011, China
Affiliated hospital of Qingdao University
Qingdao Shandong, 26600, China
Ruijin Hospital, Shanghai Jiaotong Uni. School of Med.
Shanghai Shanghai, 20002, China
Affiliated Zhongshan Hospital of Fudan University
Shanghai Shanghai, 20003, China
Huashan hospital affiliated to Fudan University
Shanghai Shanghai, 20004, China
West China Hospital ,Sichuan University
Chengdu Sichuan, 61004, China
Sichuan Cancer Hospital
Chengdu Sichuan, 61004, China
Tianjin Medical University General Hospital
Tianjin Tianjin, 30005, China
Tianjin Medical University Cancer institute & Hospital
Tianjin Tianjin, 30007, China
Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi Xinjiang, 83000, China
Yunnan Cancer Hospital
Kunming Yunnan, 65010, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou Zhejiang, 31000, China
Zhejiang Cancer Hospital
Hangzhou Zhejiang, 31002, China
Changzhou No.2 People's Hospital
Changzhou , 21300, China
Taizhou Hospital of Zhejiang Province
Taizhou , 31700, China
Institut de Cancérologie de l'Ouest
Angers Cedex 02 , 49055, France
Centre Hospitalier Intercommunal de Creteil
Créteil , 94010, France
Centre Hospitalier Universitaire Limoges CHU de Limoges
Limoges , , France
Onkologische Schwerpunktpraxis Bielefeld
Bielefeld Nordrhein-Westfalen, 33604, Germany
Asklepios Fachklinik Munchen-Gauting
Gauting , 82131, Germany
Universitätsklinikum Münster Hämatologie und Onkologie
Munster , 48149, Germany
Sana Klinikum Offenbach Gmbh
Offenbach am Main , 63069, Germany
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Orbassano Torino, 10043, Italy
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
Bologna , 40138, Italy
Azienda Ospedaliera Universitaria San Martino
Genova , , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milano , , Italy
IOV - Istituto Oncologico Veneto IRCCS
Padova , 35128, Italy
Azienda Ospedaliera Universitaria Integrata Di Verona
Verona , 37126, Italy
Jeroen Bosch Ziekenhuis - Hertogenbosch
's-Hertogenbosch , 5223 , Netherlands
Ico Badalona
Badalon Barcelona, 08013, Spain
Hospital Universitario Vall d'Hebrón
Barcelona , 08035, Spain
Hospital Universitario Arnau de Vilanova
Lleida , 25198, Spain
Hospital Universitario Gregorio Marañon
Madrid , 28007, Spain
Hospital Universitario 12 de Octubre
Madrid , , Spain
Hospital Regional Universitario de Malaga
Málaga , 29011, Spain
Clinica Universidad de Navarra
Navarro , , Spain
Hospital Universitario Virgen de la Macarena
Sevilla , 41009, Spain
Hospital Universitario Virgen del Rocio
Sevilla , 41013, Spain

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

420

Study ID:

NCT04921358

Recruitment Status:

Recruiting

Sponsor:


BeiGene

How clear is this clinincal trial information?

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